Satisfaction and anxiety are improved with the use of an easy-to-read informed consent document: a randomized multi-group study

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Informed consent is a process in which the patient is given all the information needed to decide whether to participate in a clincal trial. The signing of the informed consent document by both the patient and the investigator is the written verification of this process. Readability of most of the consents remains a problem for the US population in which half has reading skills at an 8th grade level or below.

Materials and Methods:

226 patients who were randomly assigned to either standard consent form (13th grade level) or an easy to read form (8th grade level) were evaluated

Multiple institution study including 46 sites involved with three clinical trials from the NCCTG, ECOG, and CALGB.

Comprehension of the consent, anxiety associated with the process, and satisfaction with the process were all evaluated.

Results:

Comprehension of consent content was similar between two groups

More satisfaction and decreased anxiety were observed in easy

to

read group

Authors' Conclusions

Easy readability was associated with enhanced satisfaction and reduced anxiety

Participation of clinical trials maybe enhanced by patient's satisfaction and less anxiety with informed consent process

Clinical/Scientific Implications:

The signing of the informed consent form does not, however, end the process of consent

The investigator is obligated to continue to provide relevant information to the subject, answer questions, and ensure understanding throughout the duration of the study

Continued education of patients who are enrolled in the clinical trials may also play a positive role in patient's satisfaction